Our regulatory experts bring up to 25 years each working with regulatory processes. They have been co-founding clinical research legislations in working groups chaired by the local Competent Authority. They are able to guide the client through the local regulatory processes in order to shorten the approval timelines, enabling faster start-up. As a standard, we also keep maintenance of the study including regulatory reporting, formal meetings and consultations with CA whenever required and compliance with applicable local and international guidelines throughout the study.
Some members of our team have been participating in setting-up Ethics Committees in early nineties to make sure they are compliant with GCP guidelines. It helps us to maintain streamline communnications with both Multicenter and Local ECs at all times, supporting client’s strategical planning and make the EC approval process effective. We also take complete care of EC reporting during and after the study as required by local and international guidelines.